Cleared Traditional

K955760 - TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM

K955760 is the FDA 510(k) clearance for TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM by Bayer Corp.. It is a Class 2 Microbiology device (product code LGD) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K955760 · Bayer Corp. · Microbiology device
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Aug 1996
Decision
226d
Days
Class 2
Risk

K955760 is an FDA 510(k) clearance for the TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on August 2, 1996 after a review of 226 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bayer Corp. devices

Submission Details

510(k) Number K955760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1995
Decision Date August 02, 1996
Days to Decision 226 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 102d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 76
Devices cleared under the same product code (LGD) and FDA review panel - the closest regulatory comparables to K955760.
INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
K963297 · Incstar Corp. · Dec 1996
AXSYM TOXO IGM
K954576 · Abbott Laboratories · Aug 1996
AXSYM TOXO IGG ANTIBODY ASSAY
K954575 · Abbott Laboratories · Aug 1996
IMMULITE TOXOPLASMA GONDII IGG
K950671 · Diagnostic Products Corp. · Feb 1996
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
K951495 · Bio-Rad Laboratories, Inc. · Dec 1995
IMX TOXO IGG
K951636 · Abbott Laboratories · Aug 1995